Alvotech and Advanz win EC approval for first Simponi biosimilar

20 November 2025

Icelandic biosimilars company Alvotech (Nasdaq: ALVO) and privately-held UK firm Advanz Pharma today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz, Alvotech’s biosimilar to Johnson &Johnson’s (NYSE: JNJ) Simponi (golimumab).

The authorizations cover Gobivaz 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats, for the treatment of adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for the treatment of juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate. The approvals apply across the European Economic Area.

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